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Exploring the potential of Bacillus coagulans for Parkinson's disease based on clinical need--a Single blind, randomized controlled study of clinical efficacy

Clinical efficacy observation of using live Bacillus coagulans in patients with Parkinson's disease and constipation

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087265
Enrollment
Unknown
Registered
2024-07-23
Start date
2023-11-02
Completion date
Unknown
Last updated
2024-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's patients with constipation

Interventions

control:no
Intervention Group 1:Bacillus coagulans tablets (oral, first 6 tablets, then 3 tablets, 3 times a day, 350 mg per tablet, containing not less than 5.0 × 107 CFU/g of live Bacillus coagulans), for 2 we
Intervention Group 2:Bacillus coagulans powder (Oral, 2 bags at a time, 3 times a day, containing not less than 1.0 × 109 CFU/g of live Bacillus coagulans), for 2 weeks (14 days).

Sponsors

Jiujiang University Affiliated Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) All patients met the diagnostic criteria for primary Parkinson's disease; (2) All patients met the Rome IV diagnostic criteria for functional constipation; (3) The symptoms of constipation were severe and affected the patients' quality of life; (4) Hoehn-Yahr stage 1-5 patients; (5) Age greater than 18 years old and less than 80 years old; (6) The patients gave informed consent and participated in the study.

Exclusion criteria

Exclusion criteria: (1) Patients with probiotic allergy; (2) Patients who have been treated with other medications for constipation within 30 days prior to enrollment; (3) Patients who used antibiotics or supplemented probiotics three months prior to baseline sampling and had poor compliance; (4) Secondary constipation and drug-induced constipation with clear causes; (5) Individuals who have had acute gastrointestinal diseases or surgical procedures within the past three months; (6) Combined with serious primary diseases such as cardiovascular, cerebrovascular, liver, kidney, respiratory, and hematopoietic systems, malignant tumors, and/or other progressive underlying diseases; Individuals with severe cognitive impairment and other serious neurological disorders; (7) Pregnant, lactating, and childbearing women.

Design outcomes

Primary

MeasureTime frame
Weekly Number of spontaneous complete bowel movements (SCBM);Gastrointestinal Symptom Rating Score (Wexner Constipation Rating Scale (Wexner) Score/Cleveland Constipation Scoring System (CSS);Bristol Stool Form Scale (BSFS);Patient with Constipation Quality of Life Scale (PAC-QOL) Score;Parkinson's Disease Patient Quality of Life Questionnaire (PDQ-39) scores;

Secondary

MeasureTime frame
Disease severity score (motor and non-motor symptoms; clarification of the effect of live Bacillus coagulans on motor symptoms in patients with Parkinson's disease with the help of evaluation tools such as scales UPDRS Part III);Hamilton Anxiety Inventory;Depression Scale;MMSE;Impact of MoCA;

Countries

China

Contacts

Public ContactShuhua Cheng

Jiujiang University Affiliated Hospital

chengshuhua1985@126.com+86 159 7990 4502

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026